Novartis Hiring for Global Clinical Publishing Associate

Novartis Hiring for Global Clinical Publishing Associate

Position: Global Clinical Publishing Associate
Company: Novartis
Experience: 1–2 Years
Salary: ₹4 Lacs per Year
Job Type: Work from Home
Education: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or Life Sciences
Job Type: Verified Job | Online Application

About the Role

The Global Clinical Publishing Associate will play a vital role in ensuring compliance with internal and external guidelines for clinical and regulatory documents. The position involves compiling documents, adding electronic navigation, and supporting the timely submission of documents to Health Authorities (HAs). The role also provides publishing consultancy to clinical teams and other organizational functions. Novartis Hiring for Global Clinical Publishing Associate

Key Responsibilities

• Document Compilation and Publishing:
  Collaborate with clinical teams to compile and integrate clinical documents using advanced word processing and publishing tools.
• Quality Control (QC):
  Perform technical QC checks to ensure all documents meet internal and external standards, including electronic functionality.
• Regulatory Knowledge:
  Stay updated with the latest electronic publishing standards, regulatory guidelines, and legal requirements.
• Program Support:
  Act as the Program Publisher for various programs under direct supervision.

Key Performance Indicators

• Timely Document Submission:
  Publish clinical documents in adherence to project deadlines and organizational standards.
• Quality Standards:
  Ensure documents meet all internal and external quality benchmarks, reducing the need for rework.
• Regulatory Compliance:
  Deliver high-quality submissions in compliance with regulatory requirements such as FDA, ICH, and EMA guidelines.

Minimum Requirements

• Educational Qualifications:
  B.Pharm, M.Pharm, Pharm.D, MSc, BSc, or relevant Life Sciences degree.
• Technical Expertise:
  Familiarity with regulatory submission formats, CTD criteria, and publishing activities.
• Skills:
  • Strong interpersonal, communication, and presentation skills.
  • Project management skills to handle multiple tasks simultaneously.
  • Proficiency in MS Office and other publishing tools.
  • Analytical and problem-solving capabilities.
• Regulatory Knowledge:
  In-depth understanding of FDA, ICH, and EMA guidelines and the ability to apply regulatory standards effectively.

Preferred Experience

• Cross-cultural collaboration and working across organizational boundaries.
• Expertise in Clinical Study Reports (CSRs) and operational excellence.
• Proven ability to manage projects and deliver within timelines.

Additional Information

• Work-Life Balance: Flexible work arrangements to support your personal and professional life.
• Languages: Fluency in English (written and spoken) is essential.

This is a verified job opportunity offering flexibility, professional growth, and a chance to make a significant impact in the pharmaceutical industry. Novartis Hiring for Global Clinical Publishing Associate

Apply Online Today!

More Jobs

Sarkari Jobs